As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...

With the consistent development of new apps, wearable devices are playing a growing role in monitoring our overall health. KYW medical editor Dr. Brian McDonough has more.

Examples range from ambient voice transcription tools that enable doctors or nurses to spend more time with their patients to diagnostic devices ... be seen how medical professionals and patients will ...

These platforms set Quibim apart from other companies that are applying artificial intelligence (AI ... is focused on creating medical devices that bring its breakthroughs to healthcare providers.

GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices with 80 listed 510(k) clearances or authorizations to date in the ...

Artificial intelligence (AI) is reshaping industries and our daily lives, from smart devices to healthcare and even the way ...

Artificial intelligence has many applications in ... Rather, I think Apple is going to acquire a medical device company. One area of the AI landscape that I continue to think goes overlooked ...

A China-Pakistan joint Artificial Intelligence medical diagnosis lab has started working in the ... a Chinese medical technology company that provided three cervical cancer screening devices along ...